|- candidate number||28610|
|- NTR Number||NTR7032|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-feb-2018|
|- Secondary IDs||171010 METC Isala|
|- Public Title||Detection of Asymptomatic Atrial Fibrillation in persons of 65 year of age or older|
|- Scientific Title||Detection of Asymptomatic Atrial Fibrillation in persons of 65 year of age or older|
|- ACRONYM||DETECT AF|
|- hypothesis||The smartphone connected MED as AAF is a valid screening instrument for application in transmural care in the Netherlands.|
|- Healt Condition(s) or Problem(s) studied||Asymptomatic Atrial Fibrillation|
|- Inclusion criteria|| -Age ≥65 years|
-Is giving informed consent
|- Exclusion criteria|| -Known medical history with Atrial Fibrillation|
-Not mental competent
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||15-mrt-2018|
|- planned closingdate||15-mrt-2020|
|- Target number of participants||4000|
|- Interventions||screening persons ≥65 years old for AAF (Asymptomatic Atrial Fibrillation)|
|- Primary outcome||Primary objective:|
The aim of this study is to determine the accuracy, sensitivity and specificity of the AliveCor Kardia automated AF algorithm in a transmural care setting in the Netherlands. In patients ≥65 years without symptoms associated with (A)AF.
|- Secondary outcome||Secundary objectives:|
Gain insight into AAF prevalence in the Netherlands
To determine sensitivity and specificity of the AliveCor Kardia system in combination with the added expert sECG analysis findings
To determine negative predictive value of the AliveCor Kardia system
Users and patient satisfaction about AliveCor Kardia system screening
Feasibility of screening of 4000 persons ≤2 year
Feasibility of structural implementation of the AliveCor Kardia system in community care (general practitioners and other care givers)
|- Timepoints||screening for AAF with mobile ECG device at T=0. After screening for AAF the study is ended for the patient|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Ilona Kalter|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A. Elvan|
|- Sponsor/Initiator ||Diagram B.V.|
(Source(s) of Monetary or Material Support)
|Pfizer, Daiichi Sankyo|
|- Brief summary||Rationale:|
Atrial fibrillation (AF) is the most common cardiac arrhythmia. Although the condition itself is not life-threatening, the complications result in increased morbidity and mortality. AF is often asymptomatic and a considerable number of people suffering from AF are not aware of their condition. Unfortunately, a cerebral infarction is often the first clinical manifestation. The idea to screen persons opportunistically for Asymptomatic Atrial Fibrillation (AAF) was infeasible until recently. However, with a recently-developed smartphone connected Mobile ECG Device (MED), this seems to be feasible after all.
A non WMO obligation, prospective study to examine the feasibility of screening persons of ≥ 65 year old for AAF.
The study population will consist of a large group of people with not known AF until the screening.
Main study parameters/endpoints:
• To examine the feasibility of screening persons ≥65 years old for AAF
• To validate the smartphone connected MED as AAF screening instrument for application in transmural care in the Netherlands.
The following data will be collected: age, gender, screening location, reason for screening, CHA2DS2-VASc score, sECG, sECG algorithm outcome, expert team sECG rhythm assessment , “sECG algorithm outcome vs observer assessment outcome” variability and “sECG inter- observer assessment” variability.
Nature and extent of the burden and risks due to participation:
The screening for this study will be combined with to determined visit of candidates to their family doctor or another event. The candidates have to give digital informed consent and will be asked to answer a minimum of questions (age, gender, screeninglocation, reason for screening, CHA2DS2-VASc score). Than an ECG will be made with the MED by holding a little stick with both hands.
If the automated MED automated AF algorithm gives “normal ECG” as result the study will end for the candidate.
If the MED gives “abnormal ECG” as result patient will be referred to medical healthcare for AF for further investigation and probable AF treatment.
For the study there will be no further investigation or follow-up.
All sECGs will be analysed by the sECG-expert team, if abnormalities are observed by this team the family doctor will be informed. The family doctor has the connection between the sECG code and the patient details and will contact the patient.
|- Main changes (audit trail)|
|- RECORD||19-feb-2018 - 8-mrt-2018|